Efficacy and Safety of Vitamin A Treatment for Children With Sepsis

Sichuan University

Status: Not yet enrolling

Conditions: Vitamin A Deficiency; Pediatric; Sepsis

Treatments: Drug: Vitamin A; Drug: Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT04127968

1010

Details and patient eligibility

About

The prevalence of vitamin A deficiency was found high in children with sepsis. Whether those patients will benefit from the vitamin A supplementation is unknown.

Full description

It was reported that the prevalence of vitamin A deficiency was highly as 58% in critically ill children with sepsis. However, whether those patients will benefit from the vitamin A supplementation is unknown. We design an randomized, double-blind, placebo-controlled, multi-center trial to investigate the effect of vitamin A supplementation on the outcome of critically ill children with sepsis.

Enrollment: 450 estimated patients

Sex: All

Ages: Under 192 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age < 18 years,
2. Expected to stay in the ICU for 48 hours or more,
3. Vitamin A deficiency (VA < 0.2 mg/L)

Exclusion criteria

1. Severely impaired gastrointestinal function
2. Premature infants and low birth weight (LBW) infants
3. Condition of underlying organ dysfunction
4. Having received chemotherapy or radiotherapy
5. Hematological malignancies
6. Primary or acquired immunodeficiency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 2 patient groups, including a placebo group

intervention group

Experimental group

Description:

Septic children with vitamin A deficiency who will receive vitamin A supplementation.

Treatment:

Drug: Vitamin A

control group

Placebo Comparator group

Description:

Septic children with vitamin A deficiency who will receive placebo.

Treatment:

Drug: Oil